EARTH NEGOTIATIONS BULLETIN
PUBLISHED BY THE INTERNATIONAL INSTITUTE FOR SUSTAINABLE
DEVELOPMENT (IISD)
WRITTEN AND EDITED BY:
Changbo Bai changbo@sprint.ca
Stas Burgiel stas@iisd.org
Leanne Burney leanne@iisd.org
Jessica Suplie suplie@pik-potsdam.de
Elsa Tsioumani elsat@law.auth.gr
Editor
Pamela Chasek, Ph.D.
Managing Director
Langston James Goree VI "Kimo"
Vol. 09 No. 137
Monday, 31 January 2000
Coverage of the EXCOP can be found at:
http://www.iisd.ca/biodiv/excop/
REPORT OF THE RESUMED SESSION OF THE EXTRAORDINARY MEETING OF THE
CONFERENCE OF THE PARTIES FOR THE ADOPTION OF THE PROTOCOL ON
BIOSAFETY TO THE CONVENTION ON BIOLOGICAL DIVERSITY:
24-28 JANUARY 2000
The resumed session of the Extraordinary Meeting of the Conference
of the Parties (ExCOP) for the Adoption of the Protocol on
Biosafety to the Convention on Biological Diversity was held from
24-28 January 2000, in Montreal, Canada. Over 750 participants,
representing 133 governments, NGOs, industry organizations and the
scientific community, attended the meeting. Following nine days of
negotiations, including late evening and early morning sessions,
delegates adopted the Cartagena Protocol on Biosafety in the early
morning hours of 29 January 2000.
The Cartagena Protocol addresses the safe transfer, handling and
use of living modified organisms (LMOs) that may have an adverse
effect on biodiversity with a specific focus on transboundary
movements. The Protocol establishes an advance informed agreement
(AIA) procedure for imports of LMOs, incorporates the
precautionary principle and details information and documentation
requirements. The Protocol also contains provisions regarding
documentation, confidential information and information-sharing,
capacity-building, and financial resources, with special attention
to the situation of developing countries and those without
domestic regulatory systems.
A BRIEF HISTORY OF THE BIOSAFETY PROTOCOL
The Convention on Biological Diversity (CBD), negotiated under the
auspices of the United Nations Environment Programme (UNEP), was
adopted on 22 May 1992 and entered into force on 29 December 1993.
There are currently 176 Parties to the Convention. Article 19.3 of
the CBD provides for Parties to consider the need for and
modalities of a protocol setting out procedures in the field of
the safe transfer, handling and use of living modified organisms
(LMOs) that may have an adverse effect on biodiversity and its
components.
COP-1: The first Conference of the Parties (COP-1) to the CBD,
held in Nassau, the Bahamas, from 28 November - 9 December 1994,
established an Open-ended Ad Hoc Group of Experts on Biosafety,
which met in Madrid from 24-28 July 1995. According to this
meeting's report (UNEP/CBD/COP.2/7), most delegations favored the
development of an international framework on biosafety under the
CBD. Elements favored unanimously for such a framework included:
all activities related to LMOs that may have adverse effects on
biodiversity; transboundary movement of LMOs; release of LMOs in
centers of origin/genetic diversity; mechanisms for risk
assessment and management; procedures for advance informed
agreement (AIA); information exchange; capacity-building and
implementation; and definition of terms. Elements with partial
support included: socio-economic considerations; liability and
compensation; and financial issues.
COP-2: At COP-2 in Jakarta, Indonesia, in November 1995, delegates
considered the need for and modalities of a protocol on biosafety.
Amidst debate over the Protocol's scope, the COP adopted
compromise language (Decision II/5) calling for a "negotiation
process to develop in the field of the safe transfer, handling and
use of living modified organisms, a protocol on biosafety,
specifically focusing on transboundary movement of any LMO that
may have an adverse effect on biological diversity." COP-2 also
established an Open-ended Ad Hoc Working Group on Biosafety (BSWG)
to elaborate a protocol based on elements from the Madrid report.
Other terms of reference for the BSWG state that it shall:
elaborate key terms and concepts; consider AIA procedures;
identify relevant categories of LMOs; and develop a protocol that
takes into account the precautionary principle and requires
Parties to establish national measures.
BSWG-1: At its first meeting, held in Aarhus, Denmark, from 22-26
July 1996, the BSWG elected Veit Koester (Denmark) as its Chair
and began the elaboration of a protocol on biosafety. Although the
meeting produced few written results, it functioned as a forum for
defining issues and articulating positions characteristic of a
pre-negotiation process. Governments listed elements for a future
protocol and outlined the information required to guide their
future work.
BSWG-2: Delegates to BSWG-2, held from 12-16 May 1997, in
Montreal, discussed a range of issues, including: objectives; AIA;
notification procedures for transfers of LMOs; national competent
authorities/focal points; information-sharing and a clearing-house
mechanism; capacity-building; public participation and awareness;
risk assessment and management; unintentional transboundary
movement; handling, transportation, packaging and transit
requirements; and monitoring and compliance. BSWG-2 also convened
a contact group to start defining key terms.
BSWG-3: BSWG-3 met in Montreal from 13-17 October 1997. Delegates
produced a consolidated draft text to serve as the basis for
negotiation. The meeting established two Sub-Working Groups to
address the core articles of the Protocol, as well as a contact
group on institutional matters and final clauses. Delegates
addressed outstanding issues in plenary, including: socio-economic
considerations; liability and compensation; illegal traffic; non-
discrimination; trade with non-Parties; as well as objectives,
general obligations, title and preamble for a protocol.
BSWG-4: At the opening of BSWG-4, which met in Montreal from 5-13
February 1998, delegates entered the "negotiation phase" in order
to reduce, through consensus, the number of options under each
article. Using the structure adopted at BSWG-3, delegates began
consideration of several articles that had only received
preliminary discussion at BSWG-3, including:
principles/objectives, general obligations, non-discrimination,
socio-economic considerations, and liability and compensation.
Delegates also continued work on other issues previously
addressed, including: matters relating to AIA, risk assessment and
management, minimum national standards, emergency measures and
capacity-building.
COP-4: The Fourth Meeting of the Conference of the Parties (COP-
4) to the CBD took place from 4-15 May 1998, in Bratislava,
Slovakia. In Decision IV/3, "Issues related to biosafety," the COP
extended the deadline for the negotiation of a protocol from the
end of 1998 to early 1999. It established an extra meeting to be
followed by an ExCOP to adopt the Protocol in 1999.
BSWG-5: BSWG-5 met from 17-28 August 1998, in Montreal. Delegates
consolidated options for 45 articles in the revised consolidated
draft to 40 articles, although thirteen articles remained entirely
bracketed. Polarized positions continued to emerge during
discussions over whether the Protocol's scope included "products
thereof," whether the Protocol would address questions of
liability and redress, and if the Protocol would incorporate the
precautionary principle.
BSWG-6 & EXCOP: BSWG-6 met from 14-22 February 1999, and was
immediately followed by the First Extraordinary Meeting of the
Conference of the Parties, held from 22-23 February 1999, in
Cartagena de Indias, Colombia. Despite intense negotiations,
delegates were not able to agree on a protocol, although
identifiable negotiating groups started to emerge. The main areas
of contention centered on trade issues, treatment of commodities
and domestic vs. international regulatory regimes. The ExCOP
adopted a decision to suspend the meeting and requested the ExCOP
President and the COP-4 Bureau to decide when and where the
session would resume, no later than the fifth meeting of the
Conference of the Parties. Delegates decided that the Protocol
will be called the Cartagena Protocol on Biosafety to the CBD. The
text of the draft Protocol, set out in both the Report of BSWG-6
and the ExCOP Draft Report (UNEP/CBD/ExCOP/1/L.2/Rev.1), was
transmitted to the resumed ExCOP session for further debate.
INFORMAL CONSULTATIONS: Three sets of informal consultations aimed
at facilitating discussion on key outstanding issues were held
during the period between the ExCOP's suspension and its
resumption. (Note: Since the third set of consultations
immediately preceding the resumed ExCOP, its report has been
merged with the report of the ExCOP below.)
Montreal (July 1999): Based on a decision by the COP-4 Bureau, on
1 July 1999, ExCOP President Mayr met with spokespersons from the
major negotiating groups that emerged in Cartagena: the Central
and Eastern European countries, the Compromise Group (Japan,
Mexico, Norway, South Korea and Switzerland), the European Union
(EU), the Like-Minded Group (the majority of developing countries)
and the Miami Group (Argentina, Australia, Canada, Chile, the
United States and Uruguay). At the meeting, the groups expressed
their political will to finalize negotiations and it was agreed to
hold another set of informal consultations prior to resuming the
ExCOP.
Vienna (September 1999): The second set of informal consultations
met in Vienna, Austria, from 15-19 September 1999. The first two
days of the meeting were devoted to consultations within
negotiating groups; the third day was for informal exchanges
between groups; and the final two days were devoted to resolving
differences between groups on pending core issues. During the
final two days of discussions, chaired by ExCOP President Mayr,
negotiating groups met in the "Vienna setting," a roundtable
format with two spokespersons from each group. The groups
addressed the issues of commodities, the protocol's relationship
with other international agreements, the protocol's scope and
application of the AIA procedure. Negotiating groups agreed on a
basic set of concepts for commodities and relations with other
international agreements, while acknowledging that the central
differences on those and other issues remain. The results were
forwarded as a Chairman's Summary (UNEP/CBD/ExCOP/1/INF/3) to the
resumed session of the ExCOP.
REPORT OF THE INFORMAL CONSULTATIONS AND THE RESUMED EXCOP
INFORMAL CONSULTATIONS
The third set of informal consultations were held in Montreal from
20-23 January 2000. The first two days of the informal
consultations were devoted to discussions within negotiating
groups and were chaired by ExCOP President Juan Mayr. On Saturday,
22 January, Chair Mayr opened informal discussions among the major
negotiating groups in the "Vienna setting." Chair Mayr highlighted
his non-paper, which provided suggested text incorporating the
results of the Vienna discussions on scope, application of the AIA
as it relates to commodities, and Article 31 (Relationship with
Other International Agreements) of the draft Protocol contained in
the ExCOP Draft Report. The negotiating groups provided opening
remarks in which they reiterated their political will to conclude
the Protocol.
After providing initial comments on the non-paper, Chair Mayr
proposed that consultations proceed by clustering related issues
into three groups. The first being commodities, including a new
article in Chair Mayr's non-paper on an alternative AIA for living
modified organisms intended for direct use for food or feed, or
for processing (LMO-FFPs), as well as articles in the ExCOP Draft
Report on: the application of the AIA procedure; handling,
transport, packaging and identification; information-sharing and
the biosafety clearing-house; and a new annex in the non-paper on
information requirements for notifications. The second cluster was
on scope, covering Article 4 of the ExCOP Draft Report. The final
cluster included the Protocol's relationship with other
international agreements, as well as articles from the ExCOP Draft
Report on: Parties' rights to take more protective measures than
those in the Protocol; the precautionary principle; non-
discrimination; and socio-economic considerations. On the third
cluster, the EU supported the formulation, but indicated that
discussion of other issues should not be reopened. The Like-Minded
Group requested removal of discussion on Parties' rights to take
more protective measures than those in the protocol, the
precautionary principle, and socio-economic considerations, while
the Miami Group argued to retain them.
The negotiating groups provided initial comments on the
commodities and scope clusters, which were then discussed by
contact groups on Sunday, 23 January. The "Vienna setting"
convened to hear the contact groups' progress reports. After
closing comments by the groups in the evening "Vienna setting,"
Chair Mayr indicated that he would forward the results to Monday's
resumed ExCOP and closed the informal session.
RESUMED EXCOP
Editors' Note: Respecting the confidential nature of informal
consultations and contact group meetings, the Bulletin does not
use the names of countries and/or groups in its reports of these
meetings.
On Monday, 24 January 2000, COP-4 President Laszlo Miklös
(Slovakia) welcomed delegates on behalf of the COP-4 Bureau. ExCOP
President Juan Mayr officially opened the ExCOP for the Adoption
of the Protocol on Biosafety, inviting delegates to build on the
work accomplished during the recent informal consultations. He
stressed the urgency to build on this momentum to solve
outstanding issues and to adopt the protocol as the first
international environmental treaty of the new millennium. He
encouraged Ministers to attend and drew attention to a ministerial
dinner roundtable he would host on Wednesday.
CBD Executive Secretary Hamdallah Zedan emphasized the
significance of the negotiations for the CBD and sustainable
development. He referred to the benefits of biotechnology and said
the protocol would ensure that humanity enjoys the benefits of
science and trade, while protecting the environment. He noted the
atmosphere of cautious optimism apparent during the informal
consultations and expressed appreciation to Parties that provided
financial support for the participation of developing countries
and those with economies in transition.
Delegates then adopted the provisional revised agenda (UNEP/
CBD/ExCOP/1/1/Rev.2) and its annotations
(UNEP/CBD/ExCOP/1/1/Rev.2/Add.1). Regarding the organization of
work, Mayr said that the Plenary and the "Vienna setting"
involving groups' spokespersons would be used and both would have
translation and follow official rules of procedure. He also stated
that there would not be more than two contact groups meeting in
parallel. Mayr proposed keeping the contact groups on scope and
commodities, which were established during the recent informal
consultations. Ethiopia, on behalf of the Like-Minded Group,
suggested that the contact groups be merged. Mayr invited regional
groups to submit names of three representatives for the Legal
Drafting Group to be chaired by Lynn Holowesko (the Bahamas).
Participants heard reports from the CBD Secretariat on the
credentials of representatives and on available documents,
including the Draft Report of the First ExCOP
(UNEP/CBD/ExCOP/1/L.2/Rev.1) and the Report of the Sixth Open-
ended Working Group on Biosafety (UNEP/CBD/ExCOP/1/2).
Expanding on its statement in the opening Plenary, the Like-Minded
Group reiterated the need to address related elements of Article 5
(Application of the AIA Procedure) of the ExCOP Draft Report in
discussions on scope. (Unless otherwise specified, references to
articles are as they appeared in the ExCOP Draft Report.) The EU
inquired about initiating discussions on the protocol's
relationship with other agreements. Mayr announced that the
contact group on scope would address relevant elements of Article
5, but would not discuss issues related to commodities. He further
noted that Article 31 (Relationship with Other International
Agreements) would be addressed later.
The contact group on commodities commenced discussion on Article
17 (Information Sharing and the Biosafety Clearing-House) by
drawing attention to the proposed amendments in Chair Mayr's non-
paper. On Article 15 (Handling, Transport, Packaging and
Identification), the group engaged in a conceptual discussion on
the package proposal in the text of the Draft Protocol contained
in Annex II of the ExCOP Draft Report. The group then discussed
the package proposal paragraph by paragraph. Delegates focused
their discussion on Article 9 bis (decision procedure for LMO-
FFPs) in Chair Mayr's non-paper, particularly on language dealing
with information provision subject to domestic regulations. The
group continued its discussion into the night.
The contact group on scope met in the afternoon to discuss
outstanding issues related to Article 4 (Scope), where the
negotiating groups presented their general perspectives. Upon one
group's proposal to start addressing the substance of the
exemptions, delegates discussed the status of pharmaceuticals for
humans. During an evening session, delegates continued discussions
on the scope of the protocol in relation to pharmaceuticals,
contained use and transit.
TUESDAY, 25 JANUARY 2000: On Tuesday delegates met during the
morning in the "Vienna setting" to hear contact groups' reports on
commodities and scope, as well as to begin a general discussion on
trade-related issues and the protocol's relationship with other
international agreements. Chair François Pythoud (Switzerland) of
the contact group on commodities reported on Articles 15 and 17 of
the ExCOP Draft Report stating that he would collaborate with
groups to present a Chair's text. Regarding Article 9 bis (on the
decision procedure for the review of LMO-FFPs) in Mayr's non-
paper, he noted progress on options for decision-making procedures
and capacity-building, bilateral agreements and cooperation
between Parties. Chair John Herity (Canada) of the contact group
on scope reported that negotiating groups provided complete
explanations of their positions on pharmaceuticals for humans,
transit and contained use. He also noted a proposal from the Like-
Minded Group listing articles that should not apply in these
cases.
After a round of comments on the progress reports, Chair Mayr
stressed that discussions should focus only on the list of
outstanding items in the ExCOP Draft Report. Upon a request to
raise outstanding issues mentioned in official closing statements
at the ExCOP in Cartagena, Mayr suggested that the Legal Drafting
Group could address some of these issues. After a round of
preliminary statements on the cluster of trade-related issues,
Chair Mayr closed the session so that informal discussions on
scope could proceed and the contact group on commodities could
meet.
The "Vienna setting" reconvened again in the evening to hear
reports of the contact groups. Chair Pythoud reported that the
contact group on commodities made progress and was close to a
final text in terms of concepts, but more time was required to
find balanced wording. Chair Herity reported that after informal
discussions with negotiating groups' representatives on scope, the
contact group focused on transit. He noted general agreement on
Article 4 (Scope) and its coverage of all LMOs that may have
adverse effects on biodiversity. He said that new articles
covering pharmaceuticals, transit and notification were being
developed. Chair Mayr convened a new contact group under the
chairmanship of Amb. Philémon Yang (Cameroon) to address the
cluster of trade-related issues and the protocol's relationship
with other international agreements. He stated that the contact
group on commodities would continue to meet and that discussions
on scope would proceed informally under the guidance of Chair
Herity. The contact group on commodities reconvened in the evening
to continue discussing Articles 9 bis in Chair Mayr's non-paper
and Article 15 of the ExCOP Draft Report. The contact group on
trade-related issues convened in the evening to address Articles
31 and 22 of the ExCOP Draft Report and their reformulation in
Chair Mayr's non-paper.
WEDNESDAY, 26 JANUARY 2000: On Wednesday morning, delegates
reconvened in the "Vienna setting" to hear progress reports from
the contact groups. Chair Pythoud of the contact group on
commodities presented text on the decision procedure for LMO-FFPs,
claiming that groups were close to agreement. He noted that the
group also briefly discussed Annex 1B (Information Required in
Notification) contained in Chair Mayr's non-paper. Chair Yang of
the contact group on trade-related issues reported on discussions
on the use of preambular language contained in Chair Mayr's non-
paper regarding the Protocol's relation to other international
agreements. Chair Herity of the contact group on scope reported
that informal consultations had not yet been resumed and proposed
that they continue. Mayr suggested that the contact groups on
scope and commodities be merged. He requested final text for
presentation at a late evening "Vienna setting." After discussion
regarding when to address the precautionary principle, Mayr stated
that such issues can be examined after the core issues are
resolved.
The contact group on commodities met in a morning session to
discuss text proposed by the Chair on Article 18, particularly
regarding provisions on safety conditions, accompanying
documentation and declarations that movement of LMO-FFPs conform
with the protocol's requirements. The contact groups on
commodities and scope were then merged and met in afternoon and
evening sessions, where delegates discussed a Chair's summary text
on scope, addressing pharmaceuticals for humans, transit contained
use. Co-Chairs Pythoud and Herity later presented a revised text
based on informal consultations.
The contact group on trade-related issues and the Protocol's
relationship with other international agreements met throughout
the day, where negotiating groups presented their initial views on
the issues. After a break in the evening session, Chair Yang
distributed a draft Chair's text, deleting Articles 31 and 22 of
the ExCOP Draft Report and adding three preambular provisions with
language from the Rotterdam Convention on the Prior Informed
Consent Procedure.
At 8:00 pm, Chair Mayr hosted a dinner for ministers arriving for
the final days of negotiations. At the dinner, Ministers heard
remarks from Chair Mayr as well as the Environment Minister of
Canada, David Anderson. The dinner set the stage for more informal
discussions among Ministers during the final two days of
negotiations.
The "Vienna setting" convened at 11:20 pm to hear reports of the
contact groups and a round of views on the precautionary
principle. Mayr then requested that the contact groups on trade-
related issues, and commodities and scope meet to deliver text to
the "Vienna setting" on Thursday morning. Delegates continued
informal discussions on scope and commodities through Wednesday
night and into Thursday morning.
THURSDAY, 27 JANUARY 2000: On Thursday the contact group on trade-
related issues met at 9:00 am to continue discussions. The "Vienna
setting" convened at 1:00 pm, where Chair Mayr requested all in
attendance to stand, clasp hands, and ponder how to move the
process forward. The contact group Chairs then reported on their
progress. Chair Yang of the contact group on trade-related issues
reported that consultations continued on the basis of preambular
language proposed in the Chair's draft text. Co-Chair Herity of
the contact group on scope and commodities reported that some
legal drafting issues had arisen in Article 4 (Scope) and that
acknowledgment of a state's right to allow or prohibit the transit
of LMOs still required resolution. Co-Chair Pythoud reported that
discussions on Article 18 (Handling, Transport, Packaging and
Transportation) had almost achieved conceptual agreement, although
specific elements for identification still needed discussion. On
the decision procedure for LMO-FFPs, Pythoud reported that
unresolved issues included the decision procedure for countries
without domestic regulatory frameworks, implicit consent, and
reference to the precautionary approach.
At Chair Mayr's request, negotiating groups commented on existing
proposals addressing the precautionary principle and other trade-
related provisions. Chair Mayr then expanded the mandate of the
contact group on relations with other international agreements and
non-discrimination to consider Article 8.7 on the precautionary
principle. He suggested that Pythoud serve as Co-Chair with Amb.
Yang. He requested text to review for the evening's "Vienna
setting." Negotiating groups then listed items outside of the core
clusters that needed further consideration. Chair Mayr suggested
that negotiations continue to focus on the core issues, while
informal consultations conducted by Amb. Beat Nobs (Switzerland)
take place on other outstanding issues, including Articles 21, 23
and 24.
The contact group on trade-related issues met again in the
afternoon to continue discussions on the precautionary principle,
based on text contained in the ExCOP Draft Report. After initial
discussion, Chair Yang presented draft text on the precautionary
principle for further discussion.
At 10:00 pm the "Vienna setting" reconvened to hear reports on
trade-related issues and other outstanding items. Chair Yang
reported that the contact group deliberating the precautionary
principle was considering a draft text. Amb. Nobs reported on his
informal consultations, noting general agreement on Articles 15
(Risk Assessment), 16 (Risk Management) and 25 (Illegal
Transboundary Movement), while outstanding issues remained on
Articles 24 (Non-parties), 14 (Multilateral, Bilateral and
Regional Agreements) and 26 (Socio-economic Considerations). Chair
Mayr requested Co-Chairs Yang and Pythoud and Amb. Nobs to provide
clean text by 2:00 am. He then conducted informal consultations on
the protocol's text for presentation at Friday morning's "Vienna
setting." The contact group on trade-related issues continued
discussions on preambular language.
FRIDAY, 28 JANUARY 2000: On Friday, Chair Mayr opened the "Vienna
setting" at 10:30 am, noting that a draft text of the Protocol
with brackets on remaining issues had been distributed at 2:00 am,
and that bilateral consultations had concluded at 5:45 am. He
expressed optimism that a final conclusion would be reached and
was considering how to bridge the remaining gaps. He stated his
preference to develop consensus text by the afternoon, however if
this was not possible, he would present the Plenary with a Chair's
text at 4:00 pm.
At 4:00 pm, it was announced that the final plenary would be
reconvened at 6:00 pm, which was then postponed to 9:00 and
finally to 11:00 pm. Over this period, Chair Mayr facilitated
informal discussions with negotiating groups, primarily with
regard to the precautionary principle and preambular language on
relations with other international agreements.
CLOSING PLENARY
At 11:40 pm, President Mayr opened the closing plenary session. He
called Ilona Jepsen (Latvia), President of the Credentials
Committee, to submit the report on the credentials of
representatives to the resumed session of the ExCOP. Jepsen stated
that 109 delegations were in full compliance, seven delegations
only partly complied, therefore were not in good order, and 17
delegations had not submitted their credentials. The report was
provisionally adopted with the understanding that delegations not
in order should provide their credentials within 30 days. At
President Mayr's request, rapporteur Mariangela Rebuá (Brazil)
submitted the report of the ExCOP in two parts, from Cartagena and
Montreal, included in documents UNEP/CBD/ExCOP/1/L.2,
UNEP/CBD/ExCOP/1/L.2/Add.1 and UNEP/CBD/ExCOP/1/L.2/Add.2. The
reports were adopted by the ExCOP.
Chair Mayr then suspended the Plenary just before midnight to
allow for translation of the draft text and to resume
consultations with negotiating groups focusing on Article 18 and
its provision for identification and documentation for LMO-FFPs.
Mayr reconvened the Plenary at 4:40 am. He said delegates had
resolved crucial problems due to hard work and flexibility. He
recommended adoption of the Draft Cartagena Protocol on Biosafety
(UNEP/CBD/ExCOP/1/L.5) with one amendment to Article 18(a). The
Protocol was adopted at 4:50 am. He went on to say adoption of the
protocol marked a victory for the environment and for citizens of
the entire world. UNEP Executive Director Klaus Töpfer highlighted
the historical significance of the moment. He noted his deep
admiration for Mayr and his dedicated staff. He thanked all the
"mothers and fathers" of the Protocol, especially the ministers,
BSWG Chair Veit Koester and the international cadre of experts.
The Plenary then considered the draft decision
(UNEP/CBD/ExCOP/1/L.6) on the adoption of the Cartagena Protocol
on Biosafety and interim arrangements submitted by the COP-4
Bureau. The decision consists of four parts: adoption of the
Protocol; establishment of the Intergovernmental Committee for the
Cartagena Protocol on Biosafety (ICCP); establishment of a Roster
of Experts for risk assessment and management; and administrative
and budgetary matters. FRANCE offered to host the first meeting of
the ICCP, before the end of the year 2000, which was adopted by
the Plenary.
President Mayr then invited delegations to make closing
statements. Statements were made by Canada, Argentina, Uganda,
Ethiopia, the EU, Switzerland, Hungary, Burkina Faso, Japan, the
US and Portugal. In their statements, delegates thanked President
Juan Mayr and his staff for their hard work, as well as Montreal,
Canada, and its citizens for hosting the meeting. Many delegations
expressed their appreciation to the negotiating groups. Statements
also referred, inter alia; to: the Protocol's role in the
effective development of biotechnology; support for capacity-
building; the Protocol's breakthrough on trade and environment;
and maintaining a balance among public concerns, predictability
for industry, and environmental protections. On behalf of the
majority of NGOs, the Third World Network noted that the Protocol
is the first instrument of international law to recognize the
distinct nature of LMOs and congratulated delegates for breaking
through the North-South/East-West divides to put the environment
before trade concerns. She expressed eagerness to work again with
delegates, especially on the issue of liability. The Global
Industry Coalition stated that the protocol would protect
biodiversity, while setting the direction to share the economic
and social benefits with the world.
President Mayr extended his warm gratitude to all in attendance
and adjourned the meeting at 6:00 am. After the Plenary, a brief
organizational meeting of the ICCP convened under the chairmanship
of Amb. Philémon Yang (Cameroon).
THE CARTAGENA PROTOCOL ON BIOSAFETY
PREAMBLE: The Preamble contains references to, inter alia: CBD
Articles 19, (Handling of Biotechnology and Distribution of its
Benefits), 8(g) (Managing risks of LMOs) and 17 (Exchange of
Information); CBD COP Decision II/5 (Consideration of the Need for
and Modalities of a Protocol for the Safe Transfer, Handling and
Use of LMOs); the precautionary approach; the expansion of
biotechnology and growing public concern over potential effects on
biodiversity and human health; the potential of biotechnology for
human well-being; the importance of centres of origin and genetic
diversity; and the limited capabilities of many countries to cope
with risks associated with LMOs; as well as references to the
Protocol's relationship with other international agreements and
non-discrimination.
The contact group on former Articles 31 (Relationship with Other
International Agreements) and 22 (Non-discrimination) contained in
the ExCOP Draft Report, chaired by Amb. Philémon Yang (Cameroon),
addressed the cluster of trade-related issues and the relationship
of the Protocol with other international agreements. On Wednesday,
26 January, Chair Yang invited the negotiating groups to present
their views on these articles and the proposals in Chair Mayr's
non-paper. The non-paper proposed deleting the articles and
reflecting their content in the Preamble and a new paragraph in
former Article 8 (Decision Procedure).
Regarding non-discrimination, some delegates considered a
reference to non-discrimination redundant, outside the CBD's scope
and not applicable to LMOs. Others stressed the importance of the
principle of non-discrimination for preventing conflicts between
the Protocol and other international agreements. During discussion
on this issue one group suggested removing the clause exempting
Parties' obligations to existing international agreements where
there might be serious threat to biodiversity and asked for
consideration of relevant issues in Articles 24 (Non-Parties), 26
(Socio-economic Considerations) and the precautionary principle,
as contained in Article 10 (Decision Procedure). Most delegates
argued that the former Article 31 was unacceptable, since it would
subordinate the Protocol to international trade agreements. A
Chair's text deleted Articles 31 and 22 and introduced three new
preambular clauses borrowing language from the Rotterdam
Convention on the Prior Informed Consent Procedure.
The results of the group's discussions were presented in the
plenary on Wednesday and Thursday. The CEE and Compromise Group
approved of the proposed deletion and support for preambular
language. The Miami Group suggested deleting former Article 22 and
indicated they would consider the Chair's proposed text, while the
EU suggested deleting former Article 31 and retaining former
Article 22 and stated that Chair Mayr's non-paper presents the
most balanced formulation of preambular language. The Like-Minded
Group noted its support for deleting both articles, and preference
for preambular language contained in the non-paper.
On Thursday, Chair Mayr expanded the mandate of the contact group
on Articles 31 and 22 to consider former Article 8.7 on the
precautionary principle. After lengthy discussion on the
precautionary principle during Thursday and Friday, delegates
arrived at two bracketed options for each of the following: mutual
supportiveness with other international agreements; and
compatibility with other international agreements. The final
clause, noting the intention not to create a hierarchy with other
international agreements, was also bracketed.
The final text, the result of informal consultations, includes
three new preambular clauses: the mutual supportiveness of trade
and environment agreements with a view to achieving sustainable
development; the statement that the Protocol shall not be
interpreted as implying a change in the rights and obligations of
a Party under existing international agreements; and the
explanatory statement that the above clause is not intended to
subordinate the Protocol to other international agreements.
ARTICLE 1 (Objective): The objective of the Protocol is to
contribute to ensuring an adequate level of protection in the
field of safe transfer, handling and use of LMOs resulting from
modern biotechnology that may have adverse effects on the
conservation and sustainable use of biodiversity. It references
the precautionary approach and risks to human health, and focuses
on transboundary movements.
ARTICLE 2 (General Provisions): This article outlines the general
obligations of Parties to the Protocol with regard to AIA and the
development, handling, transport, use, transfer and release of
LMOs. It reaffirms the sovereignty of States over their
territorial sea and accepts the rights of the Parties to take
action that is more protective of the conservation and sustainable
use of biodiversity, provided that such action is in accordance
with other obligations under international law, and is consistent
with the objectives and provisions of the Protocol.
In discussions on Article 18 (Handling, Transport, Packaging and
Identification), one group raised concern over the requirement for
Parties to ensure that the development, handling, transport, use,
transfer and release of any LMOs are undertaken in a manner that
prevents or reduces risk to biodiversity. After the informal
consultations on other issues conducted by Amb. Nobs this specific
requirement remained unchanged.
ARTICLE 3 (Use of Terms): This article contains definitions of,
inter alia: COP, contained use, export, exporter, import,
importer, LMO, regional economic integration organization, and
transboundary movement.
ARTICLE 4 (Scope): This article states that, in principle, the
Protocol applies to transboundary movement, transit, and handling
and use of all LMOs that may have adverse impacts on the
conservation and sustainable use of biodiversity, also taking into
account risks to human health. During the informal consultations,
substantive disagreements on scope were dealt with in a contact
group chaired by John Herity. At the end of the informal
consultations, Herity noted agreement to simplify Article 4 to
include all LMOs. Discussions on scope continued on the basis of a
summary incorporating language from the ExCOP Draft Report, Chair
Mayr's non-paper and a proposal by one of the negotiating groups
regarding exemptions. It was generally decided to move provisions
on pharmaceuticals, contained use and transit to new articles.
ARTICLE 5 (Pharmaceuticals) [new article]: This article states
that the Protocol does not apply to the transboundary movement of
LMOs that are pharmaceuticals for humans and are addressed by
other international agreements or organizations. Parties are free
to subject all LMOs to risk assessment prior to decision-making on
import.
During the informal consultations, the Miami Group noted that
pharmaceuticals generally may not have adverse impacts on
biodiversity, while the EU noted that international bodies
governing pharmaceutical issues could adequately address future
developments. On the first day of the resumed ExCOP, the contact
group on scope deliberated whether explicit reference to
exemptions would compromise the competence of the COP serving as
the meeting of the Parties to respond to future developments.
(Note: Subsequent references to the COP connote the COP serving as
the meeting of the Parties, as specified in Article 29.) Concern
was expressed regarding developments in pharmaceutical
applications, such as gene-therapy, for which no other standards
or institutional provisions exist. The Like-Minded Group supported
including LMOs for pharmaceutical use and only compromised to the
extent that the decision could be left to the COP. To address
exemptions, a summary was produced containing a positive and
negative list of which articles should and should not apply to
LMOs intended as pharmaceuticals for humans as well as for LMOs in
transit. Ultimately, it was decided that LMOs intended as
pharmaceuticals for humans would be addressed by other relevant
international agreements or organizations.
ARTICLE 6 (Transit and Contained Use) [new article]: This article
states that LMOs for transit or contained use are excluded from
the AIA procedure without prejudicing the right of a Party of
transit to regulate the transport of LMOs through its territory or
to subject LMOs intended for contained use to risk assessments or
national standards.
During the informal consultations two main issues were considered:
the inclusion of advance notification and necessary documentation
for transit, and the need to specify and adjust the definition of
contained use. On Monday, informal consultations between
representatives of the negotiating groups focused on transit and
the practical and logistical burdens of adhering to notification
for countries of transit. After continued discussions on Tuesday
and Wednesday, it was decided that the AIA procedure should not
apply to LMOs in transit and LMOs for contained use.
ARTICLE 7 (Application of the Advance Informed Agreement
Procedure) [formerly Article 5]: This article states that, subject
to Articles 5 (Pharmaceuticals) and 6 (Transit and Contained Use),
the AIA procedure, contained in Articles 8, 9, 10 and 12, shall
apply prior to the first transboundary movements of LMOs for
intentional introduction into the environment of the Party of
import. It further states that intentional introduction into the
environment does not refer to LMO-FFPs, which are governed by
Article 11 (Procedure for LMO-FFPs). It also states that the AIA
procedure shall not apply to the intentional transboundary
movement of LMOs identified in a COP decision as being unlikely to
have adverse effects on the conservation and sustainable use of
biodiversity, taking also into account risks to human health.
ARTICLE 8 (Notification) [formerly Article 6]: This article states
that the Party of export shall notify or require the exporter to
ensure notification in writing to the importer's competent
national authority prior to the intentional transboundary movement
of an LMO covered by the AIA procedure in Article 7. The
notification shall contain, at a minimum, the information
specified in Annex I (Information Required in Notification).
ARTICLE 9 (Acknowledgement of Receipt of Notification) [formerly
Article 7]: This article states that the Party of import shall
acknowledge receipt of a notification, in writing, within 90 days
of its receipt. The content of the acknowledgement must include:
date of receipt; whether the notification, prima facie, contains
the information referred to in Article 8 (Notification); and
whether to proceed according to the domestic regulatory framework
of the Party of import, provided that it is consistent with the
Protocol or according to Article 10 (Decision Procedure). The
article specifies that failure to acknowledge receipt shall not
imply consent for transboundary movement.
ARTICLE 10 (Decision Procedure) [formerly Article 8]: This article
requires Parties of import to inform the notifier, within a 90-day
period that the transboundary movement may proceed, either only
after written consent, or without subsequent written consent.
Parties are required to communicate their decision within 270 days
of receipt of notification to the notifier and the Biosafety
Clearing-House. The article then sets out four possible decisions
that Parties may take:
approval, including how the decision applies to subsequent
imports;
prohibition;
request for additional information; or
information that the 270-day timeframe has been extended by a
defined period of time.
The article specifies that a failure by a Party to communicate its
decision within 270 days shall not imply consent. Parties must
give reasons for their decision, except for unconditional
approval. Appropriate procedures and mechanisms to facilitate
decision-making will be determined by the first COP to the
Protocol.
The issue of the precautionary principle contained in former
Article 8.7, was raised during the "Vienna setting" on Wednesday
and Thursday, when Mayr asked negotiating groups to comment on
existing proposals addressing it in relation to Articles 31, 22
and alternative preambular language. The Miami Group indicated
that references in the Preamble, Article 1 (Objective) and Annex
II (Risk Assessment) were sufficient and that operationalization
in former Article 8 was not necessary. The EU, Compromise Group,
CEE and Like-Minded Group supported the existing provision in
former Article 8.7. The EU stressed that, while decisions should
be based on science-based risk assessment and non-arbitrariness,
governments should have the sovereign right to take decisions to
avert irreversible damage. The Like-Minded Group stated that
referring to the precautionary principle solely in the Preamble
would be unacceptable.
Discussions on the precautionary principle continued in a contact
group on the basis of the text contained in the ExCOP Draft
Report. One group stated that the AIA procedure forms the core of
the Protocol and that the precautionary principle, as part of the
decision procedure, should be adequately reflected in its
operational provisions. Another group stated that reference to
"adverse effect" was unclear, as well as the basis on which an
importing country could prohibit an import. A proposal by one of
the negotiating groups suggesting new language for the article was
submitted and used as the basis for discussion. The text included
two sections, one on the precautionary approach regarding import
of LMOs, and another on review of actions taken by the Party of
import in case of availability of additional scientific
information. Negotiating groups agreed to delete language on the
review of action by the Party of import.
During a line-by-line analysis of the provision, discussion
addressed two issues: the basis on which a Party of import would
be allowed to prohibit import of LMOs; and the criteria for a
solid scientific basis to trigger an importing Party to take
actions against the import of LMOs. No consensus was reached and
the Chair presented a draft text for the provision based on the
discussions.
The draft text suggested two options: the first stated that
Parties of import may have to take decisions on the import of LMOs
in order to minimize possible adverse effects, even in the absence
of scientific certainty. The second option generally stated that
lack of scientific certainty shall not prevent the Party of import
from taking a decision. The meeting was adjourned and the two
options remained bracketed.
Following Friday's informal negotiations, the first option
prevailed: Article 10.6 (former Article 8.7) permits importing
Parties to invoke the precautionary approach, which states that
lack of scientific certainty due to insufficient information of
the potential adverse effects on biodiversity shall not prevent a
Party from taking a decision on the import of an LMO. The
provision also allows Parties to take into risks to human health.
The same issue was addressed with regard to LMO-FFPs in Article
11.8. A provision on the circumstances to be defined by concerned
Parties, under which transboundary movements can take place
without written consent, was deleted as a result of Friday's
informal negotiations.
ARTICLE 11 (Procedure for LMO-FFPs) [formerly Article 9 bis in
Chair Mayr's non-paper]: Article 11 outlines the notification and
decision process for LMOs intended for direct use for food or
feed, or for processing (LMO-FFPs), including provisions, inter
alia, on: notification of the Biosafety Clearing-House for LMO-
FFPs placed on the market; exemption of field trials for LMO-FFPs;
decisions on import of LMO-FFPs under domestic regulatory
frameworks consistent with the Protocol; countries lacking
domestic regulatory frameworks for LMO-FFPs; the precautionary
principle; and developing countries' need for capacity-building
with respect to LMO-FFPs.
During the informal consultations, negotiating groups started
discussions based on Article 9 bis proposed in Mayr's non-paper.
The Like-Minded Group expressed concern over the possibility of
enabling implicit consent in Article 9 bis. The Miami Group noted
general satisfaction with the non-paper's proposal, recognized the
importance of information-sharing and documentation regarding
transboundary movement of LMO-FFPs, but emphasized that the AIA
procedure must be workable and that decision-making procedures
should consider domestic legislation more fully. The CEE stressed
the need to apply the AIA to all LMOs, and preferred a separate
paragraph dealing with LMO-FFPs. The EU stated that the non-
paper's proposal for an alternative system was useful, and,
supported by other groups, suggested moving the alternative AIA
procedure to follow former Article 8. The Compromise Group noted
that failure to respond should not imply consent. He also
highlighted that application of AIA be based on risk assessment
and capacity-building. A contact group on commodities was
established to consider this and other issues.
On Sunday, contact group Chair François Pythoud reported that new
text for Article 9 bis covered information requirements regarding
transboundary movements of LMO-FFPs, the timeframe and the means
of providing such information in advance. Two separate paragraphs
were developed to address additional information requirements,
financial and technical assistance and capacity-building in this
area. In summarizing the decision procedures for LMO-FFPs, Pythoud
noted the group's understanding that the main basis for decisions
would be domestic regulation, although groups differed on the
procedure to be followed in the absence of domestic regulations.
The Like-Minded Group affirmed that language on domestic
regulations and decisions on imports of LMO-FFPs still remained to
be discussed.
On Tuesday, Chair Pythoud requested that negotiating groups
continue discussions on the text he presented on Article 8 bis,
which had formerly been referred to as 9 bis. One group suggested
deleting a reference to consistency with this protocol because
there was no need for standardized domestic regulatory frameworks.
Other groups disagreed. In the effort to solve this problem, the
following suggestions were made: referring to consistency with the
objective of the Protocol; referring specifically to Articles 12
(Risk Assessment) and 13 (Risk Management); or using domestic
frameworks "compatible" with the protocol.
New text merging the Chair's provisions, referring to Parties with
regulatory frameworks and Parties lacking regulatory frameworks,
was presented to the contact group. One group described the
rationale behind the merger as capturing all the concepts in the
original paragraphs, while not creating a duality between Parties
that do and Parties that do not have regulatory frameworks. Some
participants expressed disappointment with the merged text, saying
that it: complicated the decision-making process, created
redundancy with other paragraphs, introduced too many new ideas,
and moved the discussion backwards. On language in the Chair's
text stating that an importing Party's failure to communicate its
decision does not imply consent, some expressed concern that it
was too prescriptive since it did not recognize that some
countries' domestic regulations could allow for implicit consent.
The contact group drafted new text to accommodate this concern.
On Thursday, Pythoud reported to the "Vienna setting," that a
number of issues remained unresolved, including: the decision
procedure for countries without domestic regulatory frameworks;
implicit consent; and reference to the precautionary approach. He
said he would continue bilateral and multilateral consultations
with negotiating groups to resolve the remaining problems. The
outstanding issues were addressed during the final informal
consultations on Thursday and Friday and were finally reflected in
Article 11 of the final Protocol text.
ARTICLE 12 (Review of Decision) [formerly Article 9]: This article
permits a Party of import to review and change its decision
regarding the transboundary movement of an LMO at any time. The
Party of import must base its decision on new scientific
information, taking into account risks to human health. The Party
must then inform the notifier and the Biosafety Clearing-House
within 30 days, giving reasons for the decision. The article also
sets out under what conditions a Party of export or notifier may
request a review, where it considers that a change of
circumstances has occurred or that additional scientific or
technical information is available. Parties of import are required
to respond to requests for review within 90 days. Finally, the
article provides for a Party of import to require risk assessments
for subsequent LMO imports, at its own discretion.
ARTICLE 13 (Simplified Procedure) [formerly Article 10]: This
article allows a Party of import to specify in advance, to the
Biosafety Clearing-House, LMOs to be exempted from AIA, as well as
when transboundary movements may proceed simultaneously with
notification, in which case such notifications would apply to
subsequent movements to the same Party.
ARTICLE 14 (Bilateral, Regional and Multilateral Agreements and
Arrangements) [formerly Article 11]: This article sets out
provisions applying to Parties who enter into multilateral,
bilateral and regional agreements and arrangements with Parties or
non-Parties regarding procedures for transboundary movements of
LMOs, which must be consistent with the objectives of the
Protocol, and not result in a lower level of protection than
provided by the Protocol. The article also requires notification
of the Biosafety Clearing-House of such agreements and allows for
an importing Party to determine that its domestic regulations
shall apply to imports, provided that it notify the Biosafety
Clearing-House.
ARTICLE 15 (Risk Assessment) [formerly Article 12]: This article
sets out the provisions under which risk assessment will be
carried out. It says that risk assessment shall be undertaken in
accordance with the provisions in Annex II and be based, at a
minimum, on information provided in accordance with the
notification procedure and other available scientific evidence in
order to identify and evaluate the possible adverse effects of
LMOs on the conservation and sustainable use of biodiversity,
taking also into account the risks to human health. The text also
states that the importer shall ensure that risk assessment is
carried out in accordance with the AIA procedure, but that the
importer may require the exporter to carry out risk assessment.
Finally, it requires the notifier to bear the financial
responsibility for risk assessment.
This article in the ExCOP Draft Report was revisited by Amb. Nobs'
informal consultation, and minor linguistic amendments were made.
ARTICLE 16 (Risk Management) [formerly Article 13]: This article
states that Parties shall establish and maintain appropriate
mechanisms, measures and strategies to regulate, manage and
control risks identified under the risk assessment provisions, and
elaborates on the measures and controls. The measures shall be
imposed to prevent adverse effects on biodiversity, and Parties
can require risk assessments prior to the first release of an LMO.
The article also states that each Party shall, in order to ensure
genomic and trait stability, endeavor to ensure that any LMO
undergoes a period of observation commensurate with its life-cycle
or before being put to its intended use. Finally, the article
states that Parties shall cooperate in identifying LMOs or
specific LMO traits that may have adverse effects on biodiversity,
taking into account risks to human health, with a view to taking
appropriate measures on the treatment of such LMOs.
ARTICLE 17 (Unintentional Transboundary Movements and Emergency
Measures (formerly Article 14): This article details the measures
that Parties are to take in the event of unintentional
transboundary movements of LMOs, including notification, provision
of information and consultation.
ARTICLE 18 (Handling, Transport, Packaging and Identification)
[formerly Article 15]: This article sets out procedures for the
packaging and identification of LMOs to be transported across
national boarders, and addresses, inter alia: measures to ensure
that LMOs are handled, packaged and transported under safe
conditions and relevant international standards, and three
differentiated minimum documentation requirements for LMO
categories.
On Monday, contact group Chair Pythoud initiated conceptual
discussions on the "package proposal" contained in Annex II of the
ExCOP's Draft Report. The significance of documentation
requirements to the implementation of the Protocol was
highlighted. Discussions focused on how proper documentation helps
Parties reduce damage in case of accidents and that without
documentation, Parties are unable to identify whether the
Protocol's provisions have been respected. One participant
proposed that LMOs be divided into three categories in this
regard: LMOs to be released into the environment requiring
stringent documentation requirements; LMOs for contained use that
should be clearly identified; and LMO-FFPs that should be
indicated as such. Others emphasized that all LMOs should be
identified, and documentation should not only apply to the first
transboundary movement, but also to subsequent movements. One
group expressed its concern over the differentiated treatment of
LMO-FFPs in terms of documentation, and highlighted that
documentation requirements must be workable for commercial actors.
One group said that this article is closely linked with other
issues such as commodities and the scope of the Protocol, and that
since his group viewed the ExCOP Draft Report as more balanced,
discussion on this article should not be reopened.
Conceptual difficulties were expressed regarding time frames and
whether LMOs currently traded in the marketplace would be subject
to the same identification requirements. Participants expressed
views on the degree of certainty a Party can expect regarding the
percentage of LMO content in a given shipment. Some suggested that
a threshold regarding what percentage of LMO content requires
identification does not exist and raises difficult legal
questions. Others indicated that it is impossible to know the
final destination of a shipment of LMOs or the exact quantity of
LMOs in a given shipment, hence identification requirements are
not obvious. In closing the discussion on the package proposal,
some expressed their desire to retain ExCOP draft text while
others wished to further explore a revised text based on the
package proposal.
Based on discussions in the contact group, Pythoud presented a
Chair's draft text on Wednesday reflecting all the principles in
the EXCOP Draft Report, while allowing for flexibility when
dealing with different categories of LMOs. Delegates addressed a
provision on the safety conditions of LMOs when handled, packaged
and transported. Certain groups expressed concern that the
application of safety measures required qualification on a case-
by-case basis and that they should only be applied "as
appropriate."
On accompanying documentation requirements during the transport of
LMOs, some groups stressed that documentation was a minimum
requirement. There was discussion on ensuring that the provision
covered not only the first, but also subsequent movements of LMOs.
Negotiating groups confirmed the need for documentation
identifying LMO-FFPs, but disagreed on exactly how LMO-FFPs should
be identified. One group proposed that "any unique identification"
in addition to "identity" of LMO-FFPs be specified. Another
supported identification of LMO-FFPs "as not intended for
intentional introduction into the environment." One group noted
difficulties with the documentation requirements for LMO-FFPs, and
requested the proposals be bracketed. Another questioned the
appropriateness and clarity of a provision requiring a declaration
that the movement of LMO-FFPs conform with the Protocol's
requirements. To clarify who should make the declaration, one
group suggested the provision should apply only to exporters. The
provision was bracketed.
One group stated that a provision requiring the meeting of the
Parties to consider the need for and modalities of developing
standards with regard to identification, handling, packaging and
transport was unnecessary. One group stated that a reference to
collaboration with other international bodies undermines the CBD
and the Protocol and suggested language referring to consultations
with other international bodies used in the ExCOP Draft Report. As
suggested by the Chair, the group agreed to bracket the entire
provision with this amendment. As the contact group's discussion
drew to a close, conceptual agreement had almost been achieved and
the negotiating groups had agreed to a differentiated approach to
accompanying documentation for LMOs and, in principle, to
identifying LMO-FFPs. However, the specific identification
requirements remained outstanding. Consultations with negotiating
groups to resolve the remaining issues continued.
During the closing Plenary, Mayr presented the final draft
Protocol and requested its adoption after changes to the this
article regarding documentation requirements. The changes
stipulated that documentation for shipment of LMO-FFPs should
state that they "may contain" LMOs and are not intended for
introduction into the environment. The COP is directed to take a
decision on the detailed requirements, including identity and any
unique identifications, within two years.
ARTICLE 19 (Competent National Authority and National Focal Point)
[formerly Article 16]: This article requires governments to
designate national focal points and competent national authorities
to liaise with the Secretariat and perform administrative
functions under the Protocol.
ARTICLE 20 (Information Sharing and the Biosafety Clearing-House)
[formerly Article 17]: This article establishes a Biosafety
Clearing-House and outlines its objectives and the types of
information that should be provided to it. Modalities of the
operation of the Clearing-House shall be considered and decided
upon by the COP serving as the meeting of the Parties at its first
meeting, and kept under review thereafter.
The contact group on commodities focused on whether Parties shall
be required to provide information regarding the transboundary
movement of LMO-FFPs and exemptions from AIA procedures according
to Articles 4, 5 and 6 to the Clearing-House. Chair Pythoud
commenced discussion on this article by drawing attention to the
proposed amendments in Chair Mayr's non-paper. One group claimed
that a broader range of information requirements regarding
national legislation is reflected in the ExCOP Draft Report than
in the non-paper proposal. He noted that it is not necessary to
limit information on national legislation to implementation of the
protocol. Another group noted that the amendment regarding
information requirements for LMO-FFPs in domestic regulations
repeats a proposed new article on decision procedure of LMO-FFPs
in Chair's Mayr's non-paper. Negotiating groups agreed to ignore
the proposed amendments in the non-paper and retain the text
contained in the ExCOP Draft Report.
ARTICLE 21 (Confidential Information) [formerly Article 18]: This
article provides for the Party of import to permit the notifier to
identify information that should be treated as confidential. It
identifies information that "may not" be considered confidential,
such as the general description of the LMOs, the name and address
of the notifier, a summary of the risk assessment undertaken and
plans for emergency response.
ARTICLE 22 (Capacity-building) [formerly Article 19]: This article
states that Parties shall cooperate in the development and
strengthening of human resources and institutional capacities in,
inter alia: safe biotechnology management training, risk
assessment and management; technological and institutional
capacities; and biotechnology to the extent that it is required
for biosafety. The article references the needs of developing
country Parties, in particular the least developed and small
island developing States, as well as countries with economies in
transition.
ARTICLE 23 (Public Awareness and Participation) [formerly Article
20]: This article requires Parties to promote and facilitate
public awareness, education and participation in the Protocol's
implementation. It requires consultation with the public in the
decision-making process and provision of results to the public,
while respecting confidential information. It calls on each Party
to inform its public about how to access the Biosafety Clearing-
House.
ARTICLE 24 (Non-Parties) [formerly Article 21]: This article
states that transboundary movements of LMOs between Parties and
non-Parties shall be consistent with the Protocol's objective, and
Parties may enter into bilateral, regional and multilateral
agreements and arrangements with non-Parties regarding such
transboundary movements. It also requires Parties to encourage
non-Parties to adhere to the Protocol and contribute appropriate
information to the Biosafety Clearing-House. During the informal
consultations conducted by Amb. Nobs on other outstanding issues,
delegates debated the wording with regard to transboundary
movements between Parties and non-Parties. Amb. Nobs' informal
consultations made minor linguistic changes.
ARTICLE 25 (Illegal Transboundary Movements) [formerly Article
23]: This article obliges Parties to adopt appropriate domestic
measures to prevent and penalize transboundary movements of LMOs
carried out in contravention of domestic measures to implement
this Protocol. It empowers the Party affected by illegal
transboundary movement to request the Party of origin to dispose
of the LMOs at its own cost. It also requires Parties to make
available to the Biosafety Clearing-House information concerning
cases of illegal transboundary movement. During informal
consultations conducted by Amb. Nobs, general edits in legal
drafting were made.
ARTICLE 26 (Socio-economic Considerations) [formerly Article 24]:
This article allows Parties to take socio-economic considerations
arising from the impact of LMOs on the conservation and use of
biodiversity into account in reaching decisions on whether to
allow imports of LMOs. Such decisions are to be consistent with
the Parties' international obligations. It encourages Parties to
cooperate in research and information exchange on socio-economic
impacts. The amendment made by the informal consultations
conducted by Amb. Nobs included a reference to Parties' domestic
measures to implement the Protocol with regard to socio-economic
considerations.
ARTICLE 27 (Liability and Redress) [formerly Article 25]: This
article states that the first COP serving as the meeting of the
Parties shall adopt a process with respect to the appropriate
elaboration of international rules and procedures in the field of
liability and redress for damage resulting from transboundary
movements of LMOs. The COP will take into account any ongoing
processes in international law on these matters and shall endeavor
to complete this process within four years.
ARTICLE 28 (Financial Mechanism and Resources) [formerly Article
26]: This article establishes the financial mechanism of the CBD
as that of the Protocol and, with regards to guidance to the
mechanism, references the need for capacity-building and financial
resources for developing countries. The COP serving as the meeting
of the Parties to the Protocol shall provide such guidance to the
COP of the CBD to consider and forward to the financial mechanism.
ARTICLE 29 (Conference of the Parties serving as the Meeting of
the Parties) [formerly Article 27]: This article states that the
COP to the CBD shall serve as the meeting of the Parties to the
Protocol and shall keep under review implementation of the
Protocol.
ARTICLE 30 (Subsidiary Bodies) [formerly Article 28]: This article
states that any subsidiary body under the CBD may serve the
Protocol upon a decision of the COP serving as the meeting of the
Parties.
ARTICLE 31 (Secretariat) [formerly Article 29]: This article
states that the CBD Secretariat shall serve as the secretariat to
the Protocol.
ARTICLE 32 (Relationship with the Convention) [formerly Article
30]: This article states that the provisions of the CBD shall
apply to the Protocol, except as otherwise provided in the
Protocol.
ARTICLE 33 (Monitoring and Reporting) [formerly Article 32]: This
article states that each Party shall monitor the implementation of
the Protocol and report to the COP on measures taken.
ARTICLE 34 (Compliance) [formerly Article 33]: This article states
that the first COP serving as the meeting of the Parties to the
Protocol shall consider and approve cooperative procedures and
institutional mechanisms to promote compliance and address non-
compliance.
ARTICLE 35 (Assessment and Review) [formerly Article 34]: This
article provides that the COP serving as the meeting of the
Parties shall evaluate the Protocol's effectiveness, including its
procedures and annexes, five years after its entry into force and
every five years thereafter.
ARTICLE 36 (Signature) [formerly Article 35]: This article states
that this Protocol shall be open for signature in Nairobi by
States and regional economic integration organizations from 15 to
26 May 2000, and at UN Headquarters in New York from 5 June 2000
to 4 June 2001.
ARTICLE 37 (Entry into Force) [formerly Article 36]: This article
states that this Protocol shall enter into force on the ninetieth
day after the date of deposit of the fiftieth instrument of
ratification, acceptance, approval or accession by States or
regional economic integration organizations that are Parties to
the Convention.
ARTICLE 38 (Reservations) [formerly Article 37]: This article
states that no reservations may be made to the Protocol.
ARTICLE 39 (Withdrawal) [formerly Article 38]: This article states
that a Party may withdraw from the Protocol after two years from
the date on which this Protocol has entered into force for a
Party.
ARTICLE 40 (Authentic Texts) [formerly Article 39]: This article
states that the original of this Protocol shall be deposited with
the UN Secretary-General.
ANNEX I (Information Required in Notifications under Articles 8,
10 and 13): This annex provides a list of biosafety-related
information required in notifications, including, inter alia:
contact information on the importer and exporter;
name and identity of the LMOs;
intended date of the transboundary movement;
taxonomic information requirements;
information on centers of origin and genetic diversity of the
recipient organism and/or the parental organisms;
description of the nucleic acid or the modification
introduced, the technique used, and the resulting characteristics
of the LMOs;
intended use of the LMO or products thereof;
quantity or volume of the LMOs;
a previous and existing risk assessment report;
suggested methods for safe handling, storage, transport and
use;
regulatory status of the LMO within the exporting State;
result and purpose of any notification by the exporter to
other States regarding the LMOs to be transferred; and
declaration that the above-mentioned information is factually
correct.
The contact group on commodities based their discussion on a new
proposed text (Annex IB) in Chair Mayr's non-paper. Delegates
agreed that several new elements should be added to the list,
including, inter alia, description of the nucleic acid of LMOs,
unique identification of LMOs, and suggested methods for safe
handling, storage and transport and use, including labeling and
documentation. Many elements from Annex I of the ExCOP Draft
Report were also retained.
ANNEX II (Risk Assessment): This annex includes more specific
detail on risk assessment, including: objective, use, general
principles, methodology, and points to consider (e.g., recipient
or parental organism, donor organism, vector, insert and/or
characteristics of modification, LMO, detection and
identification, information on intended use, and receiving
environment).
ANNEX III (Information Required for LMO-FFPs under Article 11):
This annex was added and includes a list for information required
for LMO-FFPs under Article 11. Such information includes, inter
alia:
contact information on the applicant for a decision;
contact information of the authority responsible for the
decision;
name and identity of the LMO;
description of the gene modification, technique used and
resulting characteristics of the LMO;
any unique identification;
taxonomic information on the recipient and donor organisms;
information on centers of origin and genetic diversity of the
recipient organism and/or the parental organisms;
approved uses of the LMO;
a risk assessment report consistent with Annex II; and
suggested methods for safe handling, storage, transport and
use.
A BRIEF ANALYSIS OF THE ExCOP
While shivering in the cold winds and snow of Montreal during this
last week in January, delegates were haunted by their failure to
adopt the biosafety protocol in Cartagena nearly one year ago. The
successful adoption of the Cartagena Protocol, in the early
morning hours of 29 January 2000, has exorcised those ghosts and
now allows governments, NGOs and others to look to the challenges
ahead. Characteristic of negotiation processes, the major
coalitions did not win or lose everything. "The perfect is the
enemy of the good" was heard often throughout the week, reflecting
that "perfect" is in the eye of the negotiator, which many equal a
commonly defined good. This analysis will address the substance
and dynamics of the negotiations, focusing specifically on the
role of science, the larger political context and the negotiation
process that enabled delegates to reach agreement.
THE POLITICS OF SCIENCE: The Protocol is generally designed to
address the uncertainty and incomplete nature of scientific
knowledge of how LMOs interact with biodiversity and the
surrounding environment. A central theme underlying these
negotiations was whether decision-making on risk under conditions
of imperfect knowledge is a political or technical decision. Some
proponents of a strong provision on the precautionary principle
affirmed that policy-makers are ultimately responsible for
decisions on environmental and public safety based on scientific
input since they are ultimately accountable to their citizens.
Determining the acceptable level of risk boils down to a political
decision, and is therefore open to public dialogue. Defining a
decision as "technical," exempts it from the public sphere and
transparent decision-making. The fear, expressed by others, is
that by its nature political decision-making tends to incorporate
other non-scientific social, economic and national interests. In
this view, acceptable levels of risk can and should be based on
science and a regulatory system capable of assessing what those
existing risks are.
While discussions focused on the risk and trade aspects of LMOs,
in their final statements many delegates stressed the need to turn
to capacity-building and promotion of the biotechnology industry
in the developing world. Given their experiences with the
Convention on Biological Diversity, some developing country
delegates noted that rhetoric on sustainable development will not
contribute to technology transfer, and wondered whether related
provisions and commitments in the Protocol will continue to be
downplayed. One participant emphasized that developing countries
ultimately need to control the development of their own
biotechnology industries in coordination with domestic regulatory
systems, and to avoid becoming solely the franchises or markets
for industrialized economies.
THE SCIENCE OF POLITICS: There is no doubt that the primary
conflict encountered in negotiating an agreeable Protocol centered
on trade and environment issues. Given the recent WTO Ministerial
conference, discussion focused on whether the unsuccessful attempt
to form a biotechnology working group in Seattle would strengthen
the political will to conclude a Protocol in Montreal. Some feared
that the existence of such a biotechnology group could pre-empt
discussions on trade-related issues under the Protocol. Others
thought that such a group could facilitate the technical and
regulatory dimension of trade in LMOs, assuaging the concerns of
LMO producers and exporters. Some delegates were surprised that
the final point of contention was identification and
documentation, as opposed to one of the "sexier" issues such as
the precautionary principle or the relationship with other
international agreements. Other participants noted that the
practical issue of handling and identification presents the most
tangible, and costly, initial step towards implementing the
Protocol. While compromise language balancing the precautionary
principle and relations with other agreements could and presumably
would be subjected to different interpretations, the cost of
handling and documentation was immediate and incontrovertible.
Ultimately, it will be interesting to see how the provision
pushes, or more likely, is pushed by market preferences.
While the focus in Montreal was obviously to complete an
agreement, placing the Protocol within the larger context of
national legislation and regulatory systems gives one a richer
understanding of the dialogue. A key element of the debate was
balancing a Protocol in terms of level of detail and prescription
for countries with and without such systems. Some participants
stressed that the role of the Protocol is not to serve as a
substitute in the absence of domestic systems, whereas others
indicated the need for a strong framework to facilitate their
development. Many delegates also raised issues related to domestic
approval processes and how such regulations will co-exist with the
Protocol, especially EC Directive 90/220 on the deliberate release
of GMOs into the environment.
POLITICS AND PROSE: The series of informal discussions after
Cartagena, in Montreal and Vienna, achieved two important goals:
establishing a sense of ownership for the negotiating groups, and
gradually clarifying the core conflicts that bedeviled Cartagena.
The "Vienna setting" also accentuated the nature of the
differences between the negotiating groups. Debates on scope,
commodities and trade-related issues, reflected a different set of
dynamics within and between the major negotiating groups,
revealing splits and unique alliances among both developed and
developing countries. In the final hour, many credited the mien
and bearing of ExCOP President Juan Mayr for instilling delegates
with a sense of levity and hope, along with a distinct imperative
to conclude the Protocol. His grab-bag of colored stuffed animals
used to randomly select the speaking order within the feng shui-
structured "Vienna setting" provided both comic relief, as well as
a sense of equity and transparency. Many participants discussed
the nature of proper timing within the negotiation process: when
to let the contact groups run their course; when to defer to
informal consultations; and, ultimately, when to settle the final
deadlocks behind closed doors. The absence of an official high-
level ministerial segment was notable, and many appreciated
avoiding the rhetorical, sleep-inducing declarations in favor of
Mayr's efforts to cultivate and apply the ministers' political
influence at the ministerial dinner and in informal consultations
during the last crucial stages of the negotiations.
In a historical perspective, the Protocol is a definite victory
for the CBD. During earlier negotiations on CBD Article 19.3 and
at COP-2 in Jakarta, developing countries faced significant
opposition from the North with regards to the need for a Protocol.
During the course of the biosafety working groups and the ExCOP
many participants lamented that the CBD had chosen to take on its
arguably toughest task, as opposed to addressing a less
contentious issue, such as marine or agricultural biodiversity. It
remains to be seen how the Protocol's implementation will relate
in concrete terms to international trade, domestic legislation,
technological developments and market preferences. However,
attention should also shift away from such political and social
impacts to look at how the Protocol serves its original purpose to
protect biodiversity. But in the face of rapid commercialization
and heated public debate, countries shifted to address an
increasingly pressing environmental, economic and health concern.
Many delegates expressed their hope that the Protocol would take
on a life of its own, truly reflecting the CBD's structure as an
umbrella agreement. With the bang of gavel, after eight years,
international environmental law has taken a significant step
forward in addressing trade-environment concerns and
operationalizing the precautionary principle.
THINGS TO LOOK FOR
CONVENTION ON BIOLOGICAL DIVERSITY: The fifth meeting of the CBD's
Subsidiary Body on Scientific, Technical and Technological Advice
(SBSTTA-5) will take place from 31 January - 4 February 2000 in
Montreal. The informal Advisory Committee of the Clearing House
Mechanism will meet on 29 January 2000 at the CBD Secretariat in
Montreal. A meeting of the CHM focal points is scheduled for 31
January 2000 in the ICAO building in Montreal. The Ad Hoc Working
Group on Article 8(j) will meet from 27-31 March 2000 in Sevilla,
Spain. The fifth meeting of the Conference of the Parties will
take place from 15-26 May 2000 in Nairobi. For information
contact: CBD Secretariat, World Trade Center, 393 St. Jacques
Street, Suite 300, Montreal, Quebec, Canada H2Y 1N9; tel: +1-514-
288-2220; fax: +1-514-288-6588; e-mail: chm@biodiv.org; Internet:
http://www.biodiv.org/
GENETICALLY MODIFIED ORGANISMS AND WORLD TRADE: This meeting,
organized by the Conference Committee of Stagiaires of the
European Commission, will be held on 4 February 2000 at
"Charlemagne," Rue de la Loi 170, Brussels, Belgium. For
information contact: Ida Belling; tel: +32-2-2953134; fax: +32-2-
2957332; e-mail: ida.belling@cec.eu.int; or Anna Albovias; tel:
+32-2-2952355; fax: +32-2-2957332; e-mail: st2b1@dg24.cec.be.
ROYAL INSTITUTE OF INTERNATIONAL AFFAIRS: The UK Royal Institute
of International Affairs (RIIA) and Fauna Flora International have
jointly organized a conference on "Biodiversity and Business" to
take place from 3-4 April 2000, at Chatham House, London. The RIIA
has also scheduled a conference on "Sustainability in the WTO
Millennium Round and Beyond" for 27-28 March 2000 in London. For
information, registration and fees contact: Georgina Wright; RIIA,
Chatham House, 10 St. James Square, London SWIY 4LE, UK; tel: +44-
20-79575754, +44-20-79575700; fax: +44-20-73212045, +44-20-
79575710; e-mail: gwright@riia.org.
OECD: The OECD Working Group for the Harmonization of Regulatory
Oversight in Biotechnology will meet from 2-3 February 2000 in
Paris. The OECD Edinburgh Conference on the "Scientific Aspects of
Genetically Modified Food: Assessing the Safety of GM Food" takes
places from 28 February to 1 March 2000 in Edinburgh, Scotland.
For information contact: Peter Kearns, Secretary ICGB, OECD; tel:
+33-1-45241677; fax: +33-1-45241675; e-mail: icgb@oecd.org;
Internet: http://www.oecd.org/news_and_events.
TRAINING COURSE ON BIODIVERSITY, BIOTECHNOLOGY AND LAW: The
International Institute for Tropical Agriculture and the Global
Biodiversity Institute will host the training course from 1-24
March 2000 in Ibadan, Nigeria. For information contact: Dr. John
Kilama, International Institute for Tropical Agriculture/Global
Biodiversity Institute; Wilmington; DE; USA; tel: +1-302-7642074;
fax: +1-302-7642809; e-mail: Jkilama@GBDI.org; Internet:
http://www.gbdi.org
JOINT FAO/WHO EXPERT CONSULTATION ON RISK ASSESSMENT OF
MICROBIOLOGICAL HAZARDS: The meeting will be held from 6-10 March
2000 in Rome. For information contact: FAO; tel: +39-6-57052287;
fax: +39-6-57053369; Internet: http://www.fao.org/mfcal.
THE INTERNATIONAL CENTRE FOR GENETIC ENGINEERING AND
BIOTECHNOLOGY: The International Centre for Genetic Engineering
and Biotechnology (ICGEB) in Trieste, Italy, has organized two
biosafety workshops: "Science and Policy in Risk Assessment of
Transgenic Organisms: A Case Study Approach," from 27-31 March in
Trieste, and "Advanced Research and Procedures: Case Studies for
Designated Experts" from 3-8 April 2000 in Florence. For
information contact: Dr. Giovanni Ferraiolo; ICGEB; Trieste,
Italy; tel: +39-40-3757364; fax: +39-40-226555; e-mail:
ferraiol@icgeb.trieste.it; Internet:
http://www.icgeb.trieste.it/biosafety/.
This issue of the Earth Negotiations Bulletin (c) is
written and edited by Changbo Bai , Stas
Burgiel , Leanne Burney , Jessica
Suplie and Elsa Tsioumani
The Editor is Pamela Chasek, Ph.D.
and the Managing Editor is Langston James "Kimo"
Goree . Digital editing by Ken Tong
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